Dalacin - instructions for use, dose, side effects, contraindications

Excipients: sorbitan monostearate 20.0 mg, polysorbate 60 50.0 mg, propylene glycol 50.0 mg, stearic acid 21.4 mg, cetostearyl alcohol 32.1 mg, cetyl palmitate 32.1 mg, mineral oil 64.2 mg, benzyl alcohol 10 , 0 mg, purified water qs

Description:White cream.

Pharmacotherapeutic group:Antibiotic - Lincosamide

ATX: & nbsp

J.01.F.F.01 Clindamycin

Pharmacodynamics:

Clindamycin phosphate is inactive in vitro, but quickly hydrolyzed in vivo with the formation of clindamycin, which has antibacterial activity. Clindamycin inhibits the synthesis of proteins in a microbial cell due to interaction with 50S subunit of ribosomes.

In conditions in vitro to clindamycin, the following microorganisms that cause bacterial vaginosis are sensitive: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.

Pharmacokinetics:

After application of clindamycin intravaginally at a dose of 100 mg per day, once (as a 2% cream of clindamycin phosphate) for 7 days, the serum concentration reaches a maximum after about 10 hours (4-24 hours) after administration and is the first day on the average 18 ng / ml (4-47 ng / ml), and on the seventh day - 25 ng / ml (6-61 ng / ml), while the systemic absorption is about 4% (0.6-11%) of the administered dose.

In women with bacterial vaginosis, approximately 4% of clindamycin is absorbed (with a smaller spread of 2-8%) in a similar dosing regimen, the serum concentration reaches a maximum after about 14 hours (4-24 hours) after administration and is on average 13 ng / ml (6-34 ng / ml), and on the seventh day -16 ng / ml (7-26 ng / ml).

The systemic effect of clindamycin upon administration is intravaginally weaker than when administered intravenously or intravenously.After intravaginal administration of repeated doses clindamycin almost not cumulated in the blood. The systemic half-life is 1.5-2.6 hours.

Application in elderly patients

In clinical studies of clindamycin, 2% of the vaginal cream involved an inadequate number of patients 65 years of age or older, so that the difference in the clinical response to therapy between this age group and younger patients could be assessed. In the available reports, there was no difference in the response of elderly patients and younger patients from clinical experience.

Indications:

Bacterial vaginosis.

Contraindications:

Hypersensitivity to clindamycin, lincomycin or any component of the drug.
In patients with an antibiotic-associated colitis in the anamnesis.
Age under 18 years (data on safety, efficacy not available).

Pregnancy and lactation:

Adequate controlled studies on the use of the drug in the first trimester of pregnancy have not been conducted, so Dalacin® Vaginal cream can be prescribed to women in the first trimester of pregnancy only in absolute indications, i.e.when the potential benefit of therapy with the drug for the mother exceeds the potential risk to the fetus.

In studies on animals with the introduction of clindamycin subcutaneously or inside any adverse effects on the fetus is not found, except for cases of taking the drug in doses toxic to the mother. When clindamycin is administered intravaginally in the second or third trimester of pregnancy, the incidence of congenital anomalies in the fetus is not increased it was noted. Abnormal births had place in 1.1% of women compared with 0.5% in the placebo group, if Dalacin® Vaginal cream was used in the II trimester for 7 days. The use of the drug in the II-III trimester of pregnancy is possible if the potential benefit to the mother exceeds the risk to the fetus.

It is not known whether clindamycin in breast milk after intravaginal application. Clindamycin is found in breast milk after oral or parenteral administration, so during breastfeeding, either the use of the drug should be discarded, or to stop breastfeeding, given the importance of the drug for the mother.

Dosing and Administration:

Recommended dose: intravaginally one complete applicator (5 g of cream, about 100 mg of clindamycin) preferably at bedtime for 3 or 7 consecutive days.

Instructions for use

In the package with 20 g of cream there are 3 plastic applicators, and in the package with 40 g - 7 applicators intended for the correct introduction of cream into the vagina.

- Remove the cap of the tube with cream. Screw the plastic applicator onto the threaded neck of the tube.

- Rolling the tube from the opposite end, gently squeeze the cream into the applicator. The applicator is full when its piston comes to a stop.

- Unscrew the applicator from the tube and wrap the cap.

- In the supine position on your back, pull your knees to your chest.

- Hold the applicator horizontally, gently enter it into the vagina as deeply as possible, without causing unpleasant sensations.

- Slowly pressing the piston against the stop, enter the cream into the vagina.

- Carefully remove the applicator from the vagina and discard it.

Side effects:

The safety of clindamycin vaginal cream was evaluated in both non-pregnant patients and in patients during the II and III trimesters of pregnancy.

Table of adverse drug reactions
System-organ class	Highly often ≥ 1/10	Often aboutt ≥ 1/100 to <1/10	Infrequently aboutt ≥ 1/1000 to <1/100	Rarely aboutt ≥ 1/10000 to <1/1000	Highly rarely <1/10000	Frequency unknown (can not be estimated based on available data)
Infection and parasitic diseases		Fungal infections, infections caused by fungi of the genus Candida	Bacterial infections			Candidiasis leather
Violations from the immune system			Hypersensitivity
Violations from the endocrine system						Hyperthyroidism
Violations from the sides of the nervous system		Head pain, dizziness, dysgeusia
Violations from the sides of the hearing and vestibular organs			Vertigo
Violations from side of the respiratory system, chest and mediastinal organs		Upper respiratory tract infections	Nasal bleeding
Violations from side of the gastrointestinal tract		Pain in stomach, constipation, diarrhea, nausea, vomiting	Blowing abdomen, flatulence, bad breath			Pseudomembranous colitis*, gastrointestinal disorders, indigestion
Violations from skin and subcutaneous tissue		Itching of the skin, rash	Hives, erythema			Maculo-papular rash
Violations from the side of the musculoskeletal and connective tissue		Backache
Violations from hand kidney and urinary tract		Infections urinary tract, glycosuria, proteinuria	Dizuria
Pregnancy, postpartum period and perinatal conditions		Abnormal birth
Violations from the side of the genitals and the mammary gland	Vulvovaginal candidiasis	Vulvovaginitis, vulvovaginal disorders, menstrual irregularities, vulvovaginal pain, metrorrhagia, vaginal discharge	Trichomonas vulvovaginitis, vaginal infections, pelvic pain			Endometriosis
General disorders and reactions at the site of administration						Inflammation, pain
Data laboratory and instrumental research			Deviation results of microbiological analyzes from the norm

* undesirable drug reactions detected in the post-marketing period.

Overdose:

When intravaginal application of Dalacin® cream, absorption of clindamycin is possible in amounts sufficient to develop systemic reactions.

Accidental ingestion of the drug into the gastrointestinal tract can also cause systemic effects similar to those that occur after ingestion of clindamycin at therapeutic doses.Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis (see "Side effects" and "Special instructions").

Treatment: symptomatic and supportive.

Interaction:

There is cross-resistance between clindamycin and linkomycin. In conditions in vitro antagonism between clindamycin and erythromycin.

Determined that clindamycin at the system neuromuscular transmission and, therefore, may exacerbate muscle relaxants of peripheral action, so the drug should be used with caution in patients receiving drugs of this group.

Joint use with other drugs for intravaginal administration is not recommended.

Special instructions:

Before prescribing the drug using appropriate laboratory methods should be excluded Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus, often causing vulvovaginitis.

Intravaginal application of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.

The use of clindamycin (as well as practically all antibiotics) inside or parenterally is associated with the development of severe diarrhea and in some cases pseudomembranous colitis. With the development of severe or prolonged diarrhea, the drug should be discontinued and, if necessary, carried out the appropriate diagnostic and treatment measures.

Patients should be warned that during therapy with the drug should not engage in sexual intercourse, and also use other means for intravaginal administration (tampons, douching).

Do not use the drug Dalacin® cream during menstruation.

It is necessary to postpone the initiation of therapy until the end of menstruation.

The preparation contains components that can reduce the strength of products made of latex or rubber, so the use of condoms, vaginal contraceptive diaphragms and other means from latex for intravaginal use during drug therapy and for 72 hours after use is not recommended.

Effect on the ability to drive transp. cf. and fur:

There is no reason to believe that the use of Dalacin® Vaginal cream can affect the ability to drive and control machinery.

Form release / dosage:

Vaginal cream 2%.

Packaging:

Primary: 20 and 40 grams of cream in tubes of polyethylene or aluminum foil;

Secondary: 1 tube of 20 g complete with 3 applicators or 1 tube of 40 g complete with 7 applicators with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze!

Keep out of the reach of children!

Shelf life:

2 of the year.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:П N011553 / 01

Date of registration:12.02.2010

Expiration Date:Unlimited

The owner of the registration certificate:Pharmacy and Upjohn CampaniPharmacy and Upjohn Campani USA

Manufacturer: & nbsp

PHARMACIA & UPJOHN COMPANY USA

Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation

Information update date: & nbsp18.03.2017

Illustrated instructions

Instructions

Dalacin® (Dalacin®)